A Simple Kit for the Good-Manufacturing-Practice Production of [(68)Ga]Ga-EDTA

Glomerular filtration rates for individual kidneys can be measured semi-quantitatively by a gamma camera using [(99m)Tc]Tc-DTPA, with limited diagnostic accuracy. A more precise measurement can be performed on a PET/CT scanner using the radiotracer [(68)Ga]Ga-EDTA, which has been validated in animal studies. The purpose of this study was to develop an easy kit-based synthesis of [(68)Ga]Ga-EDTA that is compliant with good manufacturing practice (GMP) and applicable for human use. The production of the cold kit and its labeling were validated, as were the radiochemical purity measurement and analytical procedures for determining the Na(2)EDTA dihydrate content in the kits. In this study, we validated a GMP kit for the simple production of [(68)Ga]Ga-EDTA, with the intention of applicability for human use.